There now seems to be agreement that safer anesthetic
care is facilitated by: 1) a better trained and better coordinated anesthesia
care team through better recruiting and improved4onger training; and 2)
more complete monitoring of the patient and the anesthesia delivery system.

An area lacking general agreement (eg., due to differing
philosophies, lack of data, etc.) is what kind of Support/Service System
is needed to facilitate item #2 - the support of monitors (both patient
and delivery system) and the anesthesia delivery system itself.

Support/Service Systems are broadly defined (for the purpose
of this discussion) as: procedures/ personnel/space/budget to facilitate
the acquisition, utilization, and service of the monitors (patient and
delivery system) and the anesthesa delivery system. Service per se is defined
as set-up, calibration, testing, troubleshooting, and repair of anesthesia
equipment (monitors and delivery system). There are several other areas
interdependent with the issues of support/service, but which are beyond
the scope of this article (e.g., education of users in the operation and
interpretation of monitors, research and development, and feedback from
the field to the manufacturers).

Equipment Accidents

The relationship between equipment performance (failure,
ease of use, etc.) has been considered by Westenskow and Cooper "2 in their
introductory articles in a special symposium in Medical Instrumentation
("Symposium on Safety in Anesthesia"). Issues of Clinical Engineering support
and the roles of anesthesia department support personnel were also addressed
in this symposium 3,4 Cooper states that "equipment failure rarely contributes
to anesthesia related injuries (less than 5% of all deaths)". Yet, these
incidents do exist and the public, legal, and regulatory communities expect
us to reduce this " 5%" incidence to near zero. Furthermore, just as there
are no hard numbers to document the role of better monitoring/delivery
systems in assuring safer anesthesia care, there are no hard numbers to
delineate the role of anesthesia Support/Service Systems in assuring better
function of monitoring/delivery systems. Preliminary data indicate that
technical assistants do seem to make a contribution to monitoring and delivery
systems, but studies in many clinical settings are needed to document what
such assistants do nationwide. (4)

It is unlikely that any study will be designed to prospectively
test & efficacy of anesthesia Support/ Service programs (i.e., no institution
would volunteer to be the control group). We, therefore must rely on common
sense and anecdotal data (i.e.-, cases of monitor and/or delivery system
failure) to guide us in a national program to improve and standardize our
Support/Service programs. How extensive should these programs be and where
will we get the budget and personnel to support them?

People Needed

In terms of in-house personnel, anesthetists who have
special experience in this area often help with managerial functions, but
it is likely that specially trained workers will be needed, especially
in many of the larger departments. It is known that many departments already
have significant efforts to train in-house personnel to assist with Support/Service
functions and in the near future a survey of the characteristics of such
personnel should be available. 5 In California, a group has been organized
on a state-wide basis to assist with coordination and communication in
this area.

The personnel available to anesthesia departments to manage
and carry our specific Support/ Service programs can be categorized in
the following ways:

1. Anesthesiologists and anesthetists with special interest
and training in equipment design, function, and service;

2. In-house (departmental) specialist ("Anesthesia Monitoring
and Equipment Specialist") who perform various functions which range from
setting up monitors to much more complex tasks including some checks and
minor repairs of anesthesia machines; (4)

3. In-house specialists (usually with a background in
Biomedical Engineering Technology i.e.-, BMET'S) who perform major repairs
and who work out of the central Biomedical Engineering Department or may
be in an advanced support group directly attached to the anesthesia department;
(3)

4. Contract Specialists i.e., service representatives
of the manufacturers and/or independent service companies.

Given the considerable implications of support of the
functions of monitors and critical life support systems (i.e., anesthesia
machines), there are serious questions concerning the recruiting, training,
and qualifications of personnel in the categories 2, 3, and 4 above. It
is likely that individuals in category 2 are largely trained on the job,
although some are likely to have backgrounds in Respiratory Therapy, Biomedical
Engineering, and other related fields. 5 Although progress has been made
in making the needs of anesthesia known to the BMET and clinical engineering
groups (at national biomedical engineering meetings, largely through the
efforts of Cooper, Welch, Newbower, and Philip of the Harvard group), it
is doubtful that this is yet reflected in training programs and certification
exams. In regard to category 4 (i.e., factory and "third party" service
representatives), they are, in many instances, likely to be well trained,
but there is no assurance that this is so, especially if "third party"
service representatives have not been to a "factory" authorized school.
Also, there is no assurance that factory authorized service representatives
are trained to standards which the larger anesthesia community would support.

In consideration of Support/Service Systems for anesthesia
departments, the issues of procedures/ space/personnel/budget are interdependent,
but the most fundamental is personnel. It is unlikely that enough are available
who have the right training. Once we have decided on the tasks which need
to be performed (a major undertaking), we can recruit/train/examine the
personnel to carry out these procedures. This takes a great deal of planning,
effort, and time. Once we know what kind of support personnel we need (and
how many such personnel), we can negotiate for space and budget.

Nevertheless, discussions as to what kinds of monitors
and delivery systems are going to be utilized are common and purchases
are proceeding at a very rapid pace independent of preplanning as to what
kind of support/service program is needed. Due to this lack of a pre-existing
Support/ Service System, anesthesia may he on a collision course for unfortunate
incidents. There is already a serious question as to whether or not we
are supporting even the machine-s/monitors that we now have. There is an
even greater question as to whether we will be able to plan and implement
a service program in time to adequately meet the needs of the next decade.

By analogy to the automobile industry, it is as though
the manufacturers and their consuming public had decided to take a 1940
car and add to it an automatic transmission, air conditioning, disc brakes,
turbo-charging, fuel injection, trip computers, and stero without retraining
the mechanics (to say nothing of the drivers), and without enlarging the
service departments. Even before we have support systems in place to deal
with yesterday's needs, the new day is upon us OR's abound with pulse oximeters,
capnometers, mass spectrometers, new indirect blood pressure monitors,
EEG analyzers, etc. and new (partially electronic) anesthesia machines
are here or just around the comer.

Proposed Action

What do we do now? The following outline and brief discussion
offers some suggested actions:

1) Evolve a plan of action on a departmental basis

a. Assess current programs and new needs;

b. Draw up a stepwise plan (timetable) to make improvements;

c. Assign specific responsibility to designated persons;

d. Negotiate with hospital for space and personnel (budget)
to establish or enlarge efforts;

e. Document methods of periodic assessment of proper operation
and results of the overall plan.

2) Review departmental Support/Service program to assure
availability of

d. Policy for division of responsibility between in-house
personnel and outside contractors (e.g., factory service personnel);

e. Documentation of manufacturer's recommendations for
service;

f. Operational manuals.

3) Support national efforts to establish guidelines for
different types and sizes of hospitals:

a. Types of in-house Suppor/Service personnel needed;

b. The type and amount of Support/Service expected from
contract organizations (e.g., factory service personnel or "third" party
service companies);

Performance standards for in-house and contract personnel
including educational and certification procedures analogous to personnel
in Respiratory Therapy and Medical Engineering (e.g., BMET's and Clinical
engineers).

A national effort is needed to survey the activity of anesthesia
Support/Service personnel (an extension of the McMahon-Thompson study)
and to define a continuum of skiffs and roles ranging from a simple "bedside"
support role all the way up to the more sophisticated repair tasks (analogous
to national certification for BMET's and others). Eventually, educational
programs may emerge that can assure the anesthesia community (prac6tioners,
hospitals, manufacturers, etc.) of a steady supply of qualified anesthesia
specialists in a broad range of important skills to assure proper and efficient
utilization and service of monitors and anesthesia delivery systems.

Dr. Frazier is Associate Professor of Anesthesiology and
Director, Division of Instrumentation and Monitoring, Emory University
School of Medicine.

In the December, 1986 issue of the APSF Newsletter, we
reported that in November, 1985, the chiefs of anesthesiology of the 13
hospitals in the Hartford, Connecticut region met and agreed to a policy
statement promulgating as a standard of care the use of pulse oximetry
for all anesthetized patients and recovery room patients and, also, the
use of capno8raphy during general anesthesia. At that time, only a minority
of the hospitals in the region were making significant use of these monitoring
modalities. The anesthesiology chiefs believed that a uniform and public
policy would help them acquire the equipment they thought was needed.

To determine the magnitude of the improvement in safety
monitoring ability in the year following the meeting, a survey was done
of the 1 3 hospitals. The chiefs furnished information concerning the number
of anesthetics per year in their institutions and the frequency of use
of pulse oximeters during regional and general anesthesia, as well as in
the recovery room, and the frequency of capnography during general anesthesia
during the month of January, 1987. To determine the frequency for the entire
region, the individual hospital rates were weighted by the number of anesthetics
in that hospital.

The survey covered a total of 78,900 anesthetics per year.
The frequency of use of pulse oximeters was 76% during general anesthesia,
71% for regional anesthesia, and I 8% during the recovery room period respectively.
The frequency of use of capnography during general anesthesia was 60%.

The chiefs were also asked to predict what the frequency
of such monitoring would he in their institutions in January, 1988. The
rates for the

greater Hartford area were estimated under the assumption
of no change in individual hospital case loads. The predicted frequency
of the use of pulse oximeters next year is 97%, 87%, and 43% during general
anesthesia, regional anesthesia, and the recovery room respectively. The
predicted frequency for the use of capnography during general anesthesia
is 86%.

We conclude that non-invasive monitoring of oxygenation
and the adequacy of ventilation has become the standard of practice in
the Hartford, Connecticut region. It appears that it is practical for this
type of change in practice standards to occur in as little as two years
when there is a consensus among the involved chiefs of anesthesia departments.

Dr. Epstein is Professor and Chairman, Department of Anesthesiology
University of Connecticut Health Center and a member of the APSF Newsletter
Editorial Board.

In the supplement of the December, 1986 Newsletter reference
is made to the airline industry. This is in regard to technological advances
in safety.

I would like to draw attention to this industry also,
but from a different viewpoint. The airline pilots to whom we are often
compared, are light years ahead of our specialty in one particular aspect,
i.e., the limitations on their hours of work. As a result the public appreciates
that at the controls there will always be a Captain who is not fatigued.

In the same vein our patients, plus the insurance industry,
would I'm sure, be very appreciative if the same could be said of anesthesiologists.

I have no idea of the part played by fatigue in anesthetic
accidents, but it must be considerable. As a practicing anesthesiologist
for 36 years, I am only too aware of the near misses when one has been
sleepless. It is customary, where I practice, to live in the hospital for
24 hours when on call. Frequently sleep is impossible and equally frequently
our most critical cases come in well after midnight.

This is a situation and circumstance that must be changed.
No anesthesiologist should be permitted to work a 24 hour shift. Would
any of us like to be subjected to the ministrations of a sleepless colleague?
Obviously if hours of work are restricted, fee schedules will have to be
adjusted accordingly.

I consider fatigue to be Enemy No. I in our efforts to
increase the safety of anesthesia. Its elimination might obviate the cacophonous
orgasm of flashing lights and warning buzzers heralding yet another anesthetic
disaster.

Patrick M.E McGarry, M.B. F.R..C.P. (C) Winnipeg, Manitoba

Machine Maintenance Stressed

To the Editor:

Dr. Meyers (APSF Newsletter, Dec. 1986) is rightly concerned
about standards for in-house technician maintenance when an inspection
sticker is applied to an anesthesia gas machine.

Maintenance of modem gas machines now embraces multiple
technologies including mechanical, electronic and computer applications
for which technicians are seldom adequately prepared. Moreover, with the
current proliferation and complexity of hospital equipment, the technicians
may also be time-limited and be able to conduct only the most perfunctory
tests. Thus their primary standard is often that of 'passing the ICAH inspection'.

For better quality control, I suggest that we pay more
attention to the capability for good maintenance. Manufacturers must provide
more self-test and diagnostic facilities in their equipment, and more informative
teaching material designed specifically for operator and technician training.
For their part, hospitals must train their technicians to be knowledgeable
in all the technologies involved, and must optimize their maintenance procedures
whereby the maintenance and performance verification can be carried out
fast and effectively. In some cases, it could be appropriate that an anesthesiology
department determine which technicians are assigned to the work, what they
know, and what they do.

The ASA and the Committee on Patient Safety and Risk Management
are to be congratulated for producing the patient safety video series.
These videotapes take a giant step in providing safety and risk management
information to anesthesiologists and anesthetists.

I have concern that tapes may gather dust after

a first viewing and new department members and residents
might be unaware of their presence. AU departments should be encouraged
to establish an ongoing annual review of these excellent videotapes.

I would like to raise the matter of fatigue as a significant
risk factor in anesthesia.

As is well known, airline pilots must be alert during
their flights. And to that end, the FAA has had, for a long time, a strict
program of work hours limitations to prevent tired pilots from piloting
airplanes and thereby endangering passengers.

What may not be known is that the State of California
(and perhaps other states as well) have analogous rules for truck drivers,
and for the same reason that the hours that airline pilots work are limited.

The work of an anesthesiologist is at least as taxing
and important as that of an airline pilot or a truck driver. Yet there
is virtually no regulation, no standard for our activities namely, the
number of consecutive work hours that an anesthesiologist can work before
he is required to stop and get some rest.

There was a malpractice suit in California in which the
judge directed a malpractice verdict against a surgeon who worked all day
and kept on working so that he was up all night with emergencies. Then,
when he went on to do his regularly scheduled 8:00 A.M. case he had a mishap.
The Judge's action was based on his common sense, not on law, not on regulations,
not on prior judicial rulings. His position, simply put was that no person,
doctor or otherwise, who works all day and continues to work all night
can be expected to perform optimally the next morning as well.

Yet this is exactly the situation in anesthesia many,
many times. Why is it permitted?

I hate to say it but I think it is chiefly a matter of
greed, income, dollars whatever you wish to call it. The remedy in this
matter would be far more drastic than any of the activities of the Foundation
to date. Regulation by some agency or authority of the hours one works
which has a direct significant effect on income will cause howls like you
never heard before

However, in order to make the case, though, on a rational
basis, I would suggest two courses of action. One enlist (pay for) the
support of scientists who are experts in the field of "shift work", which
is exactly what we do. A second approach would emulate what the Highway
Patrol does in California. Compare the incidents in anesthesia with the
work history of say the previous 24 hours of that physician. This would
require going into the insurance companies data bank and then doing detective
work through other records all of which may not be possible because of
rules of privacy.

I hope that this is a provocative letter. It is meant
to be.

M. Jack Frumin, M.D. Atherton, CA

Fatal Potassium Error

To the Editor:

A tragic death from erroneous intravenous injection of
concentrated potassium chloride solution instead of the intended diuretic
precipitated a review of our handling of potassium chloride and other concentrated
solutions throughout our hospital.

We could not identify any circumstances in which concentrated
potassium chloride solution would be needed at a moment's notice. As we
have 24-hour pharmacy intravenous preparation service, we withdrew the
vials of concentrated potassium chloride solution from the OR, ICU, and
other patient care areas to be held in the hospital's pharmacy. The pharmacy
now prepares the diluted KCI solution ready for administration to the patient
on receipt of a prescription.

This arrangement prevents a repetition of the previous
accident, which we understand from the British Medical Defence Union is
a frequent cause of accidental hospital deaths in Britain.

We have also withdrawn epinephrine in the 1: I 000 concentration
(I mg in I ml) as this also is potentially lethal. There have been many
reports of accidents when epinephrine was administered when ephedrine or
Pitocin was intended. Epinephrine 1: 1 0,000 solution is the concentration
now stocked in our operating rooms.

We would urge our colleagues to implement this policy
wherever possible. In hospitals without 24-hour pharmacy service, we would
recommend that concentrated potassium chloride solution be kept under separate
lock and key to prevent accidental confusion between KCI and NaCl vials
in the hospital's drug cupboards.

The mere presence of a skilled and certified anesthesia
practitioner at the head of the operating table surrounded by the most
advanced space-age monitoring can not by itself guarantee patient safety.
The "technoglitz" of modern monitoring notwithstanding, patient safety,
much like good detective work requires more perspiration than inspiration;
it is a function of vigilance, planning, and training. Unfortunately, all
too often, the operating room may be at the mercy of events that occur
elsewhere in the hospital.

Recently, an employee of a hospital was interrogated by
the police and later suspended after allegedly twice tampering with valves
that regulated the pressure and quantity of nitrous oxide provided to an
operating suite by a bank of cylinders. No patients were injured by the
pipeline pressure fluctuations and at the time of the tampering, the pressure
alarms promptly alerted the staff.

In a similar case, the main oxygen shut-off valve located
in the hospital laundry room, was accidentally closed by an employee who
thought that it controlled the central heating! A nearby sign identifying
it as the main oxygen shut-off valve apparently went unheeded. Low pressure
alarms functioned properly and alerted hospital personnel. The employee,
sensing something was wrong, fled the scene. While there were no reports
of problems in the operating rooms, several newborn infants were deprived
of oxygen for several minutes, according to official reports of the event.

These two "near misses" demonstrate that patient safety
requires more than just bedside skills. The recent shift in emphasis from
environmental safety affecting all patients to issues of individual patient
safety in a one-on-one setting should not lessen the importance of the
former; rather it acknowledges that all anesthesia personnel now are expected
to be familiar with the standards enforced by local jurisdictions and national
accrediting bodies, such as the I.C.A.H.

It may be timely, however, to see if you can answer the
following questions about your institution: 1) Is access to the shut-off
valves properly controlled and locked?, 2) Are the supply systems in dedicated
rooms or structures and not shared with the laundry?, 3) Can you locate
the "emergency low pressure gaseous oxygen inlet" in the central patient
gas supply? 4) Do you know where the two master alarm signal panels are
as well as the area alarms for all anesthetizing locations? How recently
were they tested?

For guidance in this area, anesthesia personnel have traditionally
looked to the National fire Protection Association which in the past has
issued pamphlets on the safe use of inhalation anesthetics (56A), non flammable
medical gas systems (56F), emergency power (76A) and the safe use of electricity
in patient care areas (76B) to mention but a few of their publications
of importance to anesthesia. Recently, however, the N.F.P.A. has combined
them into one authoritative manual entitled "NFPA 99-Health Care Facilities,
1987 Edition". This document (NFPA U8-99-87) should be in the library of
all anesthesiologists and anesthetists; it may be obtained from the N.EP.A.,
Batterymarch Park, Quincy, MA 02269-9904 for S 17.50 plus a $2.85 handling
charge. Monitoring may detect a problem, but knowledge can prevent one!

Topic Prepared by David E. Lees, M.D., Professor and Chairman,
Department of Anesthesia, New York Medical College and a member of the
APSF Newsletter Editorial Board.

Dr. Gravenstein examines monitoring through three different
lenses. Each reveals a different view as he scrutinizes the variables we
monitor and how we have chosen them. Through @his examination we are shown
the various forces which specify and mold our clinical practice.

Monitoring is classified according to its purpose, either
to aid clinical management or to assist detecting and diagnosing physiologic
aberrations. This paper concentrates on the latter.

Essential monitoring is equated with minimal monitoring
and may be measured by the prevalence of monitor use. "Once a monitoring
practice has been adopted by the majority of anesthesiologists, 51% to
99% that practice becomes a standard".

The first lens allows us to view monitoring as it affects
outcome. Outcomes from anesthesia are classified as unremarkable or adverse.
An outcome is adverse if it is remarkable because of prolonged hospital
stay or impaired post-operative well-being (ill-being). Onset of ill-being
is usually acute, but infections and other complications can have delayed
onset. Duration can be either transient or prolonged.

Through one portion of this first lens, we see that it
was not scientific data concerning outcome that led us to our current choice
of monitors. Indeed, even after years of common use, we find no scientific
evidence of improved outcome attributable to any of them. Nonetheless,
some of our present monitors do stand the test of logical analysis. They
seem to be measures of well-being or ill-being. They provide quantifiable
data that guide us in protecting or improving our patient's state.

Unfortunately, for many measured variables, it is difficult
to define the point at which well-being slips into ill-being. We have little
data to determine what range of blood pressure is acceptable in any patient
or population of patients. Indeed, thresholds for clinical action vary
even among experts. As years have passed, our collective wisdom has shifted.
Unacceptable hypotension of the 1940's (below 120180) became the acceptable
hypotension of the 60's, 70's and 80's.

The second lens explores the relationship between the
variables we monitor and true measures of the patient's state. Dr. Gravenstein
defines the patient's state as the state of the vital cell, a hypothetical
cell which represents the heart and the brain. None of the variables we
monitor let us view the actual state of the vital cell. At best, we view
its input cascade. For the vital variable 'cellular oxygen tension', we
monitor a series of variables which begin with pipeline oxygen pressure,
pass through flow meters and a circuit-pressure gauge, and end with arterial
oxygen saturation. Although we monitor numerous precursor variables, we
are blind to the crucial variables that measure the state of the vital
cell.

We thus acquiesce to monitor only the output of the vital
cell to evaluate its state. Ideally, we would measure aggregate cellular
output which represents electrical or chemical activity and is independent
of organs and systems. Examples include the ECG which demonstrates electrical
activity and is independent of mechanical performance. Temperature is another
example. Instead, we usually measure integrated organ function (output)
which fails to detect or identify specific state derangements. We do so
because "monitoring has grown topsy-turvy and without the guidance of logic
or insight".

The third tens clarifies the actual factors which have
molded our monitoring practices; most are non-clinical. Anesthesiologists
have been rigid in their ways and have resisted change. With many modalities,
there has been a long delay from demonstration to adoption. This is because
each newly offered variable was of questionable utility in clinicians'
minds. Even capnography failed to gain acceptance in the U.S. until pulse
oximetry eclipsed its impact.

To some degree, pressures from society, especially the
legal community, have caused us to reassess our practices. "Lawsuits result
as soon as the public recognizes that mistakes rather than fate may be
responsible for an adverse outcome.. A verdict can firmly set a minimal
standard."

In summary, most monitors considered essential were adopted
by anesthesiologists because they believed that these monitors improved
the outcome for the patient, even without scientific evidence. Only now
are investigators beginning to measure the impact of monitoring on outcome.

Safety in anesthesia involves attention to detail and
the ability to make proper decisions from the data available. The data
comes from monitoring. To date, monitoring has been the major factor in
the recent push towards total patient safety in anesthesia. The recent
strong emphasis on monitoring has been so sudden that many of us have been
caught unprepared for the rapid onslaught of changing technology, bewildering
array of devices, and mandatory standards.

These drastic, relatively sudden changes in monitoring
have forced us to buy expensive, sometimes complex devices that many anesthetists
are not prepared to cope with; if they cannot cope with them, they may
not use them, or they may use them improperly. Monitoring used improperly
can be worse than no monitoring at all.

We need to know how to use our monitors, what they can
do, what they cannot do, how to interpret the information that they provide,
how to integrate the information from all of the monitors, how to troubleshoot
a monitor, and when to buy a new one. Finding help in this area has not
been easy, partly because the sources of information are so widely scattered:
anesthesia, critical care, bioengineering, and engineering journals; obscure
journals with limited distribution; poorly distributed proceedings; textbooks
that are out-of-date before they are published, or literature from the
manufacturer.

Inadequate Information

Unfortunately, even the information that has been available
has not been sufficient. For example, there has not been enough information,
other than anecdotal, to establish that any monitoring improves safety
or saves lives. Information is also sparse on how to apply monitors and
how to use the information that they give. The presence of a journal that
encourages the exchange of information on these topics will help increase
the availability of that information.

The Journal of Clinical Monitoring has approached these
problems in many ways. First, it has improved communication between the
innovators and manufacturers on the one hand and the users on the other,
emphasizing clarity of presentation. We do not receive the technical training
in medical school; they do not have the clinical insight that requires
years to accumulate. Only by understanding each other can monitoring improve
safety.

The Journal has strived to improve safety in many ways,
most of them quite conventional: original articles, reviews, tutorials,
medical intelligence, and case reports. The early years of monitoring emphasized
the cardiovascular system. Lately, however, it has become apparent that
over half of the major critical incidents are related to a lack of supply
of oxygen to the tissues. Thus, the newer monitoring equipment has shifted
towards respiration, a shift that is reflected in the journal. As a matter
of fact, the Journal seems to be caught up in this trend: about one-third
of its submissions are related to respiration, including pulse oximetry,
capnography, and mass spectrometry. These are the very areas where a rapid
dissemination of knowledge is essential for safety.

In exploring new ways to improve safety, the journal has
been as practical as is consistent with W science. One of the most popular
of the Journal's innovative sections is the Clinical -Controversies, which
has covered such topics as where should a central venous catheter be placed,
when should it be placed, do we monitor too much, which is better the pulse
oximeter or the transcutaneous oximeter, are evoked potentials useful in
the OR, should we monitor alveolar and inspiratory concentrations of anesthetic
and respiratory gases?

Future Controversies ask equally important questions:
does monitoring make a difference in patient safety? Now that we have oximeters
and capnometers, do we need continuous stethoscope monitoring Should we
monitor patients receiving epidural opiates? Does mean arterial pressure
have any physiological significance? Does one need a waveform with a capnometer?
Is measuring drug concentrations needed in the OR? What one monitor would
you take to a third world country?

Learn Equipment

Another feature that promises to be equally useful is
one that will start in the next issue: "Knowing Your Monitoring Equipment".
In this section we shall ask the designers and manufacturers of commonly
used monitoring equipment to explain how the equipment works and how it
should be operated. Frequently such information is not available to the
clinician because the manuals that come with the equipment often do not
answer all the questions, sometimes they are written mom for the engineer
than for the physician, and finally most equipment comes with only one
manual, which is needed by many and often not available when needed.

The first essay will deal with the new method of continuous
blood pressure employing the Penaz method, which is incorporated into a
device marketed by Ohmeda under the trade name Finapres TM. In preparation
is an essay dealing with infrared capno8raphy. In the planning stage are
papers on pulse oximetry and electrocardiography. Readers who collect their
issues of the Journal of Clinical Monitoring will accumulate over the years
a valuable library on the operation of commonly used monitoring equipment.

Sometimes safety appears in the least expected places.
For example, there is work on an EEG-based algorithm for detecting awareness
during anesthesia. A reliable method for detecting awareness is important,
because of the tendency to give an excess anesthetic to cover all patients,
with possible unpleasant intraoperative or postoperative consequences for
the occasional patient who is too sensitive to the anesthetic.

The Future

Monitoring will continue to change, and to change rapidly.
Thus, the Journal will help the clinician prepare for the future by emphasizing
now the future: automated record keeping, including voice recognition;
servo control of drugs, machines, ventilators, etc.; monitoring of drug
levels; continuous intravascular monitoring; and specific technologies,
such as Raman spectroscopy.

This is your journal. Although the Editorial Board can
assure high quality and readability, only you can let us know how well
we have succeeded in our goals whether we have succeeded in helping you
improve on patient safety in the operating room. What type of material
or topics do you need to help you implement this important goal?

And please consider the journal as a medium for transmitting
your ideas and thoughts to your colleagues. Manuscripts are always welcome.
If you are interested in submitting a manuscript, please read over the
Information for Contributors, to be found in the back of each issue. If
you are interested in a subscription, either for yourself, or for your
hospital, school, or departmental library, please contact Little, Brown
and Co., 34 Beacon Street, Boston MA 02106, (617) 890-0250.

Dr. Smith, (an editor of the Journal of Clinical Monitoring),
Department of Anesthesiology, V.A. Medical Center, San Diego, CA; is also
an APSF Director.

The Anesthesia Patient Safety Foundation sponsored a workshop
entitled "SAFETY AND COST CONTAINMENT IN ANESTHESW' on February 27 and
28, 1987. It was hosted by the Department of Anesthesiology of the University
of Florida in Gainesville and made possible through a generous grant from
Ohmeda.

Anesthesiologists, attorneys, insurance experts, manufacturers,
and risk managers were the invited participants. While these professionals
interact on many levels, they rarely have an opportunity to exchange ideas
and they often find it difficult to understand what motivates their counter
parts. The workshop was divided into several sections:

Setting the Stage

Dr. W.K. Hamilton from the University of California, San
Francisco opened the meeting with a timely reminder that we have permitted
anesthesia care to become more expensive than is necessary for the sake
of safety. Then, Dr. F.W. Cheney from the University of Washington in Seattle
offered an overview of the risks associated with anesthesia. He and his
coworkers concluded from an analysis of national closed-claims data that
better monitoring might reduce anesthetic mortality.

While we know that anesthesia does cause some patient
morbidity and mortality, even among the healthy undergoing minor operations,
it is most difficult to obtain scientifically valid statistics on the true
incidence. What is known about the epidemiology of anesthesia as it relates
to untoward events and the problems that have plagued workers in this field
was discussed by Dr. I.B. Forrest from the University of Ontario.

The Financial Impact of Adverse Outcomes in Anesthesia

Perspectives on the financial impact of adverse outcomes
in anesthesia were discussed from several vantage points: by an economist,
Kay Plantes, by Mark D. Wood from the St. Paul Insurance Company, by James
C. Rinaman, Jr., an attorney, by Burt A. Dole, president of Puritan-Bennett
and, finally, by Dr. P.O. Bridenbaugh from the University of Cincinnati.
Workshop participants were astonished to learn how far the consequences
of a mishap in the operating room can reach and that some of the ripples
are magnified into veritable tidal economic waves affecting not only physicians
and their insurance premiums but also the companies and their ability to
finance research and development. The section vividly demonstrated the
extraordinary interdependence between the anesthesiologist, the hospital,
and the many professionals who supply equipment, insurance, or defense
when necessary. Dr. Bridenbaugh echoed points raised by Dr. Hamilton: defensive
medicine may increase the cost of anesthesia care; but there is hardly
an anesthetic that could not be rendered less expensive without sacrificing
safety.

How to Improve Safety in Anesthesia

A section dealing with ways to improve the safety of anesthesia
was introduced by I.E Holzer, an attorney-risk manager from Boston who
described the role of the risk manager. What anesthesiologists can do to
adopt safe practice patterns was reported by Dr. S.M. Duberman from New
York. Dr. E.C. Pierce, President of the Anesthesia Patient Safety foundation,
recounted the steps for greater safety taken by the profession as a whole.
That the efforts of physicians and risk managers cannot exist in vacuum
was the theme of W. Cleverley, a health care finance specialist from Columbus,
Ohio, and G. Gore a defense lawyer from Cleveland, Ohio. Dr. Cleverley
discussed the difficulties faced by hospitals in a world of changing rules
under which capital expenses and operating costs are reckoned. Mr. Gore
reminded the audience that adherence to fairly simple and well recognized
rules will not only increase safety but also make it easier to defend an
anesthesiologist in court, should that ever become necessary.

How Financial Decisions Touching on Safety are Made

In a section on financial decision-making for safety and
thrift, the different players in the field were introduced to each other.
Each makes demands on the other and each faces constraints. The budgeting
process and the competition among clinical department heads in a large-for-profit
hospital, was described by Mr. I.M. Birnbaum, an attorney and administrator
from New York. The budgeting process in a large for-profit hospital chain
was explained by Mr. P. Powell from Humana. The clinician's perspective
was presented by Dr. J.H. Modell from the University of Florida.

What everyone wants to know, namely how insurance premiums
are set was revealed in a spirited exposition by Mr. P. Sweetland from
the New Jersey Physicians Insurance Company. Finally, Mr. T. Gibson from
Ohmeda explained why and how the financial impact of safety in anesthesia
pinches the manufacturer. The-physicians who were unaware of the repercussions
faced by manufacturers learned about the far-reaching consequences of clinical
successes and failures in the operating room.

Current Issues that Affect Safety and Cost

Several speakers addressed timely problems that confront
the specialty. Dr. R.J. Kitz from Harvard presented the history of the
Harvard and ASA minimal monitoring standards and viewed these within the
framework of other general standards that have long since become almost
unnoticed in the fabric of our society. Of course, standards have their
drawbacks and these were enumerated by Dr. R.K. Stoelting from Indianapolis.
Even the best standards on monitoring will contribute little to safety
if the clinician on the scene cannot respond to signals presented by the
monitors. Thus, education of anesthesiologists and nurse anesthetists may
play as big or bigger a role than standards for monitoring. Dr. A.L. Schneider
from Hershey, Pennsylvania reported on the current educational requirements
in anesthesia which appear impressive, until one looks at performance standards
well established in other fields, such as the aviation industry. Captain
B. Beach from Eastern Airlines informed the audience on the exacting and
well established performance standards in commercial aviation. The contrast
was striking.

Commercial aviation, of course, is used to another standard
that has no equal in medicine, that of the so-called black box. These devices
record both the voices in the cockpit and much data on the performance
of the plane and its engines during a flight. In anesthesia, we still generate
hand written records that may or may not contain the information that would
allow not only timely clinical decisions but also an analysis of problems,
should an adverse outcome have resulted because or in spite of the efforts
of the medical team. Dr. C.E. Whitcher from Stanford described the first
generation of automated anesthesia record systems and their advantages,
while Dr. 1. Eichhom from Boston detailed the potential disadvantages,
including the concern that the automated record keeping devices has engendered
among some who fear automatically recorded artifacts and, also, the absence
of both helpful and incriminating data on the hand-written anesthesia chart.

The Proceeding Will Be Published

All participants praised the opportunity to exchange opinions
and concerns with representatives from different fields, all of whom contribute
in their own way to anesthesia and the safety of patients. The proceedings
of this unique workshop will be published by Butterworths and the date
of publication will be announced in the APSF Newsletter.

Dr. J.S. Gravenstein, University of Florida, is on the
Executive Committee, Anesthesia Patient Safety Foundation.

Question: My department of six physi6ans and eight
CRNA's has no real quality assurance pro8ram. How do we get started?

Answer: Learning which a departmental quality assurance
program involves a series of steps that include:

(1) Learning which activities should be included in a
quality assurance program and what these activities involve.

Departmental quality assurance programs are instituted
in order to ensure that good quality patient care is both possible and
present within the department. It is necessary to determine that conditions
are adequate to provide good care (in terms of staff qualifications and
numbers, physical facilities, equipment, and other resources, and administration);
that good care is provided by department members; and finally that outcomes
are appropriate

Activities that help to meet these goals include problem
identification, evaluation, resolution, and reassessment to ensure resolution;
evaluation of appropriateness of care; proper maintenance of equipment
and other resources; monitoring of events and trends; and establishment
of appropriate standards, guidelines, protocols, or policies.

Relevant literature and techniques for carrying out these
activities should be explored.* Learning about the experiences of colleagues
who have already set up quality assurance programs in their own departments
is very helpful.

(2) Identifying the individual(s) or committee responsible
for setting up the program.

To be effective, departmental review and evaluation of
patient care should involve as many staff as possible.

The support and input of the chairman is crucial if the
plan is to be taken seriously. In addition, when the issue of provider
performance is raised, it may be appropriate for the chairman to act through
established channels created by the medical staff bylaws or other hospital
procedures, rather than through a departmental committee

All members of the department should have input into the
planned quality assurance activities and should understand what will be
expected of them in terms of compliance with criteria for evaluation of
care and with specific policies.

However, for any quality assurance activity to be carried
out successfully, it is important to identify the individual or committee
responsible for implementation of that specific activity, and to ensure
that the responsibility is recognized. This is equally true in identifying
those individuals responsible for gathering the information necessary to
set up the quality assurance program and for writing an initial plan to
be reviewed and commented on by other members of the department.

(3) Identifying regulations and requirements that will
affect the form and/or content of the program.

Requirements and regulations placed on the anesthesiology
department by the hospital, the state and federal governments, and the
JACH affect the administrative form of the program, the specific activities
carried out, and the content of criteria and policies. These rules and
regulations should be investigated when planning the program. Also, the
public health laws governing the discoverability of quality assurance findings
and the protection of medical personnel involved in quality assurance activities
vary from state to state. Proper handling of matters such as maintaining
confidentiality of data, writing of policies, methods of documentation
and reporting, and dealing with issues of provider performance must be
considered.

Therefore, in establishing or altering a quality assurance
program, appropriate legal counsel should be sought.

(4) Assessing existing departmental and hospital quality
assurance activities that can be included or adapted for inclusion.

Many of the activities necessary to a departmental quality
assurance program may already be in place, although some may not be well
coordinated or documented. It is important to inventory all existing department
activities related to quality assurance as the preliminary plan is developed.
For some activities it only will be necessary to document what is already
being done. For some activities it will be possible to determine that expansion,
reorganization, or modification can result in quality assurance activities
that meet current expectations or requirements. For other activities it
will be necessary to develop new parts of the program. AU of these activities
eventually can be integrated into a consolidated quality assurance program.

The organization of the hospital's quality assurance program
and the hospital's facilities can have significant effects on the mechanics
of the departmental program. Utilizing available data sources and personnel
from the hospital may avoid duplication of work, thereby reducing time,
effort, and cost. The hospital may employ quality assurance nurses or other
personnel to help the department, or the record room may be able to retrieve
pertinent data from charts. These opportunities should he thoroughly investigated.

(5) Using this information to develop a quality assurance
plan to meet the specific needs of the department.

While many of the techniques applied to, and the problems
identified from, quality assurance activities will be similar from department
to department, no two departments are identical. There are variations in
staffing, patient characteristics, numbers of patients, surgical procedures,
anesthetic procedures, locations of services, local requirements, affiliation,
teaching status, and unique problems and issues. All these must be considered
when developing a program that will meet the specific needs of the department.

It is important to remember that setting up a quality
assurance program is only the first step in running a successful program.
Quality assurance programs evolve as problems are identified and solved
and new ones are discovered, as techniques are found to be inadequate for
the needs of the department and are changed, as requirements change, and
as new methods of quality assurance develop. These programs should be periodically
reviewed and revised.

Answer by Stephanie M. Duberman, M.D., Columbia University,
New York and a member of the 9-ISF Board of directors.

*Editor's Note: "Quality Assurance in the Practice if
Anesthesiology 1986," written by Dr. Duberman, was published in October
1986 by the American Society of Anesthesiologists. It expands on the material
summarized in this column and covers additional topics. It also contains
a bibliography that will help individuals find information about quality
assurance activities.

Recognizing the need for personal involvement by individual
anesthesiologists, the North Carolina Society of Anesthesiologists (NCSA)
organized its 1986 annual meeting in Asheville to focus on a comprehensive
strategy to link safety in anesthesia with a plan to implement risk management.

Moderators from the NCSA were Drs. Jerry Calkins and Dana
Hershey (President). In organizing this seminar, NCSA leadership in private
practice and academics recognized that the current crisis in the cost of
medical liability insurance mandates that attention be directed toward
risk management and patient safety to reduce the number and severity of
anesthesia-related mishaps, For example, although the percentage of anesthesia
medical liability claims involves only three or four percent of the total
for all of medicine, the indemnity paid out exceeds I 11%. This underlines
the importance of severity in the anesthesia cases and the absolute need
to reduce risk, especially for hypoxia. Strategy should include combining
facts, time, and effort directed at a safety program while working toward
the more lengthy process of tort reform.

The program was structured for the first day to define
the problems of risk management and liability and on the second day to
propose solutions to the problems from different perspectives (i.e., the
national and state level, the insurance industry, the manufacturers' viewpoint,
the hospital administrators' overview, and a comprehensive strategy for
linking a focus on patient safety, risk management, and malpractice reform).

Dr. Eichhorn opened the seminar by enumerating the enormous
settlements and judgments presently drawing attention in the news media.
He noted that anesthesiologists in their practice were more likely to be
involved with severe, debilitating injuries than most other physician specialists;
that possibly up to 2,000 ASA I patients die per year in the United States;
and that a significant number of these deaths from available data appear
to be preventable. In reviews of closed and open anesthesia-related claim
abstracts, he enumerated that certain types of problems recur while variations
in classification make comparisons difficult. These common complications
include inadequate ventilation, difficult endotracheal intubation, esophageal
intubation, accidental extubation, ventilator disconnects, bronchospasm,
and relative or absolute anesthesia overdosase. However, anesthesiology
is uniquely fortunate in that early detection of mishaps through use of
newer sophisticated monitoring and technological advances is likely more
possible than in any other specialty. Moreover, if one were to compare
the purchase cost of monitoring devices with the skyrocketing cost of medical
liability insurance, the capital outlay for monitoring equipment becomes
small indeed. Dr. Eichhorn summarized his opinion regarding the solutions
to the malpractice crisis as follows: tort reform extremely unlikely; insurance
reform extraordinarily unlikely; system reform essentially impossible;
and reduction of patient injuries the only hope. Our job as anesthesiologists
seems clear.

Insurance View

Mr. Wood then presented the perspective from the insurance
industry by explaining that insurance indemnity functions as a system of
risk sharing where the financial resources of the group are made available
to pay for the losses of individual members. The biggest problem in insuring
the anesthesiologist is the fact that when the losses do occur, they frequently
are catastrophic in nature.

For example, preliminary dosed-claims data demonstrate
that 22% of cases were hypoxia related, those cases consumed 57.2% of the
indemnity, the per case cost was $403,500, and that, alarmingly, 80% of
cases were ASA I and If patients. He emphasized that the solution for any
anesthesiologist becomes an unwavering resolve to improve the efficacy
of anesthetic techniques and to make the best use of available technology
for early diagnosis and treatment of hypoxemia and reduction of iatrogenic
injury to patients due to anesthetic administration.

Industry Perspective

Mr. Dole explained the viewpoint of the anesthesia equipment
industry on safety and risk management. Noting that users and manufacturers
of health care equipment are merely different a= of the same effort, he
outlined the status of Puritan Bennett (P-B) as a leader in critical health
care research and manufacturing. However, despite P-B products' excellent
safety record and despite modest liability claims and settlements, product
liability insurance cost rose 656% in 1986. Their cost per $ 1,000 of insurance
coverage increased 2700% for the same period while three of their primary
insurance carriers become insolvent.

The tort system in 1986 is broken, expensive, inefficient,
slow, and wasteful. As a result, industry is being forced to raise prices
at a time when the national priority is to control costs and reduce health
care expenditures. Consequently, an overwhelming demand has occurred for
new legislation in order to guarantee a more reliable and predictable method
of assessing damages and fault. As a plan for action, he noted that in
the voluntary sector, representatives of the Health Industry Manufacturers
Association are meeting with their counterparts at the American Medical
Association in an effort to present a more unified

front in the health care field to gain much needed tort
reform in liability coverage. In much of the business and industry of health
care, new research and development monies are being channeled towards patient
safety and reduced labor costs. As the home health care market expands,
rapidly increased attention is being given to the safe use of such products
and the associated potential of liability risk. Mr. Dole closed by emphasizing
that a major step forward has been taken with the establishment of the
Anesthesia Patient Safety Foundation to focus specific resources of personnel
and funds on an educational program for anesthesiologists. This unique
effort is targeted to develop grassroots interest in patient safety and
risk management. He noted that we need to change public perception. "We
are doing a good job. Why are we on the defensive rather than the offensive?"

Hospital Position

Mr. Petasnick discussed the malpractice reform issue from
the standpoint of hospital administration. "This is a team effort a partnership!"
He noted the shared responsibility of the hospital and anesthesiologists
to ensure a safe environment, the cost effectiveness of risk avoidance,
and realistic strategies to work out a collaborative relationship between
hospital administration and the medical staff. Mr. Petasnick's experience
has been that in many operating rooms in hospitals in North Carolina, anesthesiologists
have begun to expect automated, non-invasive blood pressure apparatus;
pulse oximeters; and even end-tidal PCO2 devices in addition to the already
present electrocardiogram, oxygen analyzer, high and low pressure alarm,
and temperature monitoring capabilities. He noted in his own institution
how he had heard frequently from anesthesiologists emphasizing safety and
risk management. Moreover, surgeons were beginning to recognize the early
warning signal of the oximeter registering desaturation at unexpected moments
as well as during endotracheal intubation. Pulse oximeters are even proceeding
into the recovery room to aid in patient management and safety. There seemed
no doubt that many large liability awards for hypoxic accidents could have
been prevented by the provision of better monitoring equipment for the
anesthesiologists. He further emphasized that with the constraint on the
hospital capital equipment budget, an honest and realistic assessment rather
than a "wish 6t" would demonstrate integrity and promote relationships
necessary to help negotiation among health care colleagues. He applauded
anesthesiologists for taking the lead in managing risk and being the first
to emphasize patient safety. Mr. Petasnick closed by asking anesthesiologist
leaders to approach their hospital administrator with a comprehensive three-
to-five year plan including full disclosure of initial cost and maintenance,
personnel (upgraded if necessary) needed for the new technology, a prioritized
list of needs, and to maintain an ongoing dialogue using the candor necessary
to build trust and understanding.

APSF Role

Dr. Pierce shared with the audience the genesis of the
Anesthesia Patient Safety Foundation. In October, 1984, the first meeting
of the International Symposium on Preventable Anesthesia Morbidity and
Mortality was held in Boston under the auspices of the Royal Society of
Medicine Foundation and the Harvard Medical School. Following this successful
international meeting of invited experts, symposium members considered
the future direction should include establishment of a safety foundation.
Subsequently, the 1985 House of Delegates of the American Society of Anesthesiology
embraced Dr. Pierces proposal for a safety foundation. The Anesthesia Patient
Safety Foundation was established as an independent organization with 50%
of its board of directors as ASA members and an administrative support
office at the ASA headquarters in Park Ridge, Illinois. The 30-person board
of directors has been constituted to include 15 anesthesiologists, as well
as representatives from equipment manufacturers, CRNA anesthesia, the insurance
industry, the legal profession, the American Hospital Association, and
the Federal Food & Drug Administration. The mission established was
"to insure that no patient shall be harmed by the effects of anesthesia."

Dr. Pierce has gone on record by stating that "today it
is simply unacceptable to allow cost containment and inertia to prevent
utilization of state-of-the-art anesthesia and monitoring apparatus. No
government official or hospital administrator would ever fly in an airplane
without up-to-date equipment and safety devices." The only difference Dr.
Pierce stated in the deaths that he can see is that "anesthesia deaths
occur one at a time, whereas in the airline industry they occur in large
numbers at once".

Revolution and Crisis

Dr. Vaughan was asked to give an overview of the health
care revolution in which we find ourselves, the liability crisis, and reflect
on how our health care colleagues can become allies in the battle. He noted
that our U.S. health care revolution includes tremendous cost (over 460
billion dollars spent in 1986 on U.S. health care); population demographics
with aging and increased health needs and costs for Medicare and Veterans
Administration recipients (Table 1); a huge budget deficit developed over
that last six years (greater than one trillion dollars) introducing the
severe political crisis in how to control costs; the enormous technology
changes that seem almost beyond our ability to afford; and the ethical
and moral dilemma presented to physicians to decide who lives, who dies,
and who gets how much of what cam The liability coverage issue has become
one of unavailable insurance coverage for small business and high risk
providers as well as affordability for high risk providers especially with
capitated reimbursement schemes (i.e., Massachusetts).

Despite U.S. health cares success in becoming a miracle,
an exportable resource, the envy of the world, and phenomenal, it has been
severely

criticized as inefficient, wasteful, subject to abuse
and responsible for collosal costs in an emerging "medical arms race7'
for lithos (helicopters), lithos (lithotripters), and nucleos (MRI's).
Dr. Vaughan summarized the "malpractice lottery" as involving four players
(Figure 1). The loser on all accounts becomes American society with maldistribution
of minimal benefits for the exorbitant cost of settlements. The present
system appears out of control. For example, while $.30 of each malpractice
dollar goes to the victim of malpractice, $.70 goes to overhead expenses
to reimburse lawyers, court costs, and expert witnesses. Dr. Vaughan suggested
a plan which would start with the individual anesthesiologist, having each
emphasize a program of saw and risk management by focusing on better monitoring
and standards for each of our practices (Figure 2). An ongoing participatory
dialogue would address the tort reform issue over time enlisting the assistance
of our health care allies in an all out effort to eliminate the malpractice
lottery and distribute appropriate compensation to injured patients and
family.

Finally, all speakers agreed that anesthesiology was a
specialty uniquely positioned to control its fate in terms of risk management.
The members of the North Carolina Society of Anesthesiologists agreed in
subsequent discussions that the tort system was indeed broken, wasteful,
inefficient and unfair, and quite slow (three to five years) to settle
claims. North Carolina anesthesiologists are attempting through their practices
to demonstrate commitment to the principles enumerated by the Anesthesia
Patient Safety Foundation while continuing to speak actively to government
and employers as patient advocates in health care.

Dr. Vaughan is Professor and Chairman, Department of anesthesiology,
University of North Carolina at Chapel Hill.

The ASPAN (American Society of Post Anesthesia Nurses)
Standards of Nursing Practice have been revised and are available for purchase
through the ASPAN office.

These updated Standards now include the following areas

Pre Anesthesia

PACU

Ambulatory Surgery Unit

The Standards are based on the concept of the Nursing
Diagnosis and the Nursing Process and include Management Standards as well
as Clinical. The American Society of Anesthesiologists has recently endorsed
these Standards, available in a convenient handbook size.

The Anesthesia Patient Safety Foundation Newsletter is
the official publication of the nonprofit Anesthesia Patient Safety Foundation
and is published quarterly in March, June, September, and December at Overland
Park, Kansas. Annual membership: Individual $25.00, Corporate $500.00.
This and any additional contributions to & Foundation are tax deductible

The opinions expressed in this newsletter are not necessarily
those of the Anesthesia Patient Safety Foundation or its members or board
of directors.